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This chapter explains the highest possible standards of evidence to apply to clinical research programs of digital therapeutics (DTx). If the integrity of the DTx approach is open to question, there is a real risk that the potential of DTx to do great societal goodwill be strangled at birth. The DTx industry needs to recognize that healthcare is a serious business, caring for vulnerable people who need treatment and who deserve the best treatment. It is a privilege and not for the faint-hearted. DTx are best considered as a novel modality of medicine in which software delivers therapeutic interventions directly to a patient, usually targeting a specific disease, to generate a measurable clinical outcome. In the same way that active ingredients in pharmaceuticals are responsible for the drug’s mechanism of action, software content and algorithms in digital therapeutics are used to prevent, manage, or treat a medical or psychiatric disorder or disease.

Original publication





Book title

Digital Therapeutics: Strategic, Scientific, Developmental, and Regulatory Aspects

Publication Date



59 - 98